Daunorubicin injection bulk supplier for pharma manufacturers

Daunorubicin Injection 20 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Intravenous (IV) injection:

Available Strengths: 20 mg/mL

Reference Brands: Cerubidine(US)

Daunorubicin inhibits DNA synthesis by intercalating between DNA bases and inhibiting topoisomerase II, leading to cell death. It effectively treats leukemia, especially acute myeloid leukemia. Benefits include rapid tumor cell reduction, improved remission rates, and enhanced survival prospects, making it a potent chemotherapeutic agent.

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Product Description: Daunorubicin injection, marketed as Cerubidine, is approved in the US by the FDA and in the EU via EMA for treating leukemia, primarily acute myeloid leukemia. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, submission involves detailed review by the FDA, whereas in the EU, the EMA ensures compliance with regional quality standards. For expert guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring adherence to regional regulations is essential for the safe, effective, and timely approval of daunorubicin injection worldwide, supporting optimal patient treatment outcomes.

Daunorubicin Injection — third party manufacturing & bulk supply

Daunorubicin Injection 20 mg/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Daunorubicin Injection is supplied as Intravenous (IV) injection: — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Daunorubicin Injection listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Daunorubicin injection is listed as Intravenous (IV) injection: in 20 mg/mL. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Daunorubicin injection is referenced against Cerubidine(US). Reference brands are shown for identification only and remain the property of their respective trademark owners.